Tension-type HeadacheNCT01601015
Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy
A study testing Manual Therapy in people with Tension-type Headache, run by University of Valencia at 1 site in Spain.
Trial summary
Background. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective. Objective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-type Headache
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 and 65 years
- Diagnosis of frequent ETTH and CTTH
- Having headache episodes on more than 1 day per month
- Headache episodes lasting from 30 minutes to 7 days
- Headaches having at least 2 of the following characteristics:
- Bilateral location of pain
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- Pressing non pulsating quality
- Mild or moderate intensity
- Not aggravated by physical activity
- Sufferers may present photophobia, phonophobia, nausea or vomiting
- Headache may be associated with pericranial tenderness
- Suffering from TTH for over 3 months
- Subjects being under pharmacological control
Who cannot join
- Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.
- Headache that is aggravated by head movements.
- Metabolic or musculoskeletal disorders with symptoms similar to headache
- Previous neck trauma
- Vertigo, dizziness, arterial hypertension.
- Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
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- Patients with heart devices
- Patients in process of pharmacological adaptation
- Excessive emotional tension
- Neurological disorders
- Laxity of neck soft tissues
- Radiological alterations
- General hypermobility or hyperlaxity
- Joint instability
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy in the Perception of Pain and Cervical Motion: a Double-blind, Randomized, Placebo-controlled Clinical Trial.
Background. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective.
Objective. The purpose of this study is to know the effectiveness of manipulative and manual therapy treatments, with regard to pain perception and neck mobility in patients with tension-type headache.
Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed with tension-type headache, divided into three treatment groups -manual therapy, manipulative therapy, and a combination of both techniques-, and a placebo control group. Four treatment sessions were administered during four weeks, with post-treatment assessment, and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly register).
- Conditions
- Tension-type Headache
- Being tested
- Manual Therapy, placebo treatment
- Keywords
- Tension-type headache, Effectiveness, Manual therapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Also called Tension-type Headache
Manual therapy of Suboccipital soft tissue Inhibition is performed with patient in supine position. The patient's head leans against the physiotherapist's hands, which palpate suboccipital muscles by sliding fingertips until contacting posterior arch of atlas. At this point, a deep and progressive gliding pressure is applied, for 10 minutes. The purpose of this technique is to release suboccipital muscle spasm, which can be responsible for the mobility dysfunction of the occiput-atlas-axis joint.
Manual TherapyOther
Also called Tension-type Headache, manipulation
Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.
Manual TherapyOther
Also called Tension-type Headache, Manipulation
Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.
placebo treatmentOther
Also called Resting position, Tension-type Headache
The physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
The control group received four sessions of placebo treatment, followed by ten minutes of resting position.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Manual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction. Receives: Other: Manual Therapy |
| Occiput-atlas-axis joint manipulation | Experimental | Is bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction Receives: Other: Manual Therapy |
| Combined treatment | Experimental | The group receiving combined treatment received the two previous techniques exactly with the same sequence. Receives: Other: Manual Therapy |
| Control group | Placebo comparator | Control group not receive treatment and stayed in this position for 10 minutes Receives: Other: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
An individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)
Firstly, socio-demographic data and characteristics of headache were collected during the four weeks prior to the treatment through individual clinical interview carried out by a physiotherapist who did not participate in the outcome assessment nor in the administration of treatments. It included age and sex, location of pain, side dominance of pain, type of pressure, connection with physical activity, frequency, severity of pain, associated symptoms and pain intensity, rated by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).
Measured: up to 4 weeks
Secondary outcomes (3)
Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
includes the following aspects: a) sensory, description of pain in time-space terms; b) affective, description of pain in terms of stress, fear and neurovegetative aspects; and c) evaluative, pain described in terms of general assessment. The McGill Pain Questionnaire is validated in Spanish population [13, 14] and it consists of 66 word descriptors divided into 20 groups, including in each group between 2 and 6 adjectives describing pain. Moreover, it includes a section in which patients register the intensity of pain.
Measured: up to 8 weeks
Cervical ranges of motion, measured with the CROM-device
The CROM-device combines a system of inclinometers and magnets set on a head mainframe with a nose-piece (positions like eyeglasses) and it measures angles of flexion, extension, lateral flexion and rotation. As it includes a system of magnets, the CROM must not be used in subjects with heart devices.
Measured: up to 8 weeks
Weekly register
Frequency and intensity of headache, assessed with a seven register weekly. Patients recorded headache frequency as well as intensity of pain measured by the VAS Scale
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tension-type HeadacheStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma Victoria Espí López, PhD, Principal investigator, Physiotherapy Department. University of Valencia. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601015
- Sponsor's protocol ID
- UVT002
- Status last verified
- May 2012
- First submitted
- 11 May 2012
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011 Jan;31(2):133-43. doi: 10.1177/0333102410377362. Epub 2010 Jul 20.
PubMed 20647241
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy in the Perception of Pain and Cervical Motion: a Double-blind, Randomized, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01601015
- Acronym / sponsor ID
- UVT002
- Conditions
- Tension-type Headache
- Keywords
- Tension-type headache, Effectiveness, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective.
Objective. The purpose of this study is to know the effectiveness of manipulative and manual therapy treatments, with regard to pain perception and neck mobility in patients with tension-type headache.
Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed with tension-type headache, divided into three treatment groups -manual therapy, manipulative therapy, and a combination of both techniques-, and a placebo control group. Four treatment sessions were administered during four weeks, with post-treatment assessment, and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly register).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Manual TherapyManual therapy of Suboccipital soft tissue Inhibition treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction. |
| Occiput-atlas-axis joint manipulation | Experimental | Other: Manual TherapyIs bilaterally administered. The aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction |
| Combined treatment | Experimental | Other: Manual TherapyThe group receiving combined treatment received the two previous techniques exactly with the same sequence. |
| Control group | Placebo comparator | Other: placebo treatmentControl group not receive treatment and stayed in this position for 10 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects aged between 18 and 65 years
- Diagnosis of frequent ETTH and CTTH
- Having headache episodes on more than 1 day per month
- Headache episodes lasting from 30 minutes to 7 days
- Headaches having at least 2 of the following characteristics:
Key exclusion criteria (15 listed)
- Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyAlso: Tension-type HeadacheManual therapy of Suboccipital soft tissue Inhibition is performed with patient in supine position. The patient's head leans against the physiotherapist's hands, which palpate suboccipital muscles by sliding fingertips until contacting posterior arch of atlas. At this point, a deep and progressive gliding pressure is applied, for 10 minutes. The purpose of this technique is to release suboccipital muscle spasm, which can be responsible for the mobility dysfunction of the occiput-atlas-axis joint. | Other | Manual therapy |
| Manual TherapyAlso: Tension-type Headache, manipulationOcciput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction. | Other | Occiput-atlas-axis joint manipulation |
| Manual TherapyAlso: Tension-type Headache, ManipulationOcciput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction. | Other | Combined treatment |
| placebo treatmentAlso: Resting position, Tension-type HeadacheThe physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups. The control group received four sessions of placebo treatment, followed by ten minutes of resting position. | Other | Control group |
Primary outcome
An individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)
Time frame: up to 4 weeks
Firstly, socio-demographic data and characteristics of headache were collected during the four weeks prior to the treatment through individual clinical interview carried out by a physiotherapist who did not participate in the outcome assessment nor in the administration of treatments. It included age and sex, location of pain, side dominance of pain, type of pressure, connection with physical activity, frequency, severity of pain, associated symptoms and pain intensity, rated by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).
3 secondary outcomes
Multidimensional perception of pain, assessed by the McGill Pain Questionnaire
Time frame: up to 8 weeks
Cervical ranges of motion, measured with the CROM-device
Time frame: up to 8 weeks
Weekly register
Time frame: up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
- Results publication: PubMed 20647241Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011 Jan;31(2):133-43. doi: 10.1177/0333102410377362. Epub 2010 Jul 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma Victoria Espí López, PhD principal investigator
Physiotherapy Department. University of Valencia. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Tension-type Headache, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks) (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.